The need fulfilled by chelation therapy treatment is to remove toxic or undesirable metals such as lead, mercury, cadmium, calcium, and the like from living bodies. For example, excessive concentrations of lead are accumulated in a subject's body through ingestion of contaminated water from lead plumbing, fish from contaminated water, lead in paints, pesticides, lead used in manufacturing processes, and by inhalation of air contaminated by auto emissions, lead smelting and the like. Mercury accumulates from sources similar to lead. Mercury also leaches out of amalgam fillings used in dental work. Calcium is a building block of the cholesterol/triglycerides plaque which builds up in human vascular systems. This plaque consequently leads to coronary problems, blood circulation problems, strokes, and the like.
The preferred modality which has developed to remove these metals has been chelation therapy treatments, administered intervenously.
Intervenous (I.V.) treatments are very effective, but have proven to be inconvenient, time consuming, and expensive. I.V. treatments further require skilled personnel and a suitable environment such as a clinic to be administered. All subjects, both human and animal, are reluctant to receive I.V. treatments on a continuing basis. The typical I.V. chelation therapy treatment takes a minimum of about three hours per treatment and the treatments may be administered at intervals of one to six times a week to a total of thirty to ninety treatments, or more, for example. The blind testing required by government agencies and some professional groups for I.V. chelation treatment has proven to be very difficult and almost impossible to conduct to complete satisfaction.
As an advantage over I.V. Chelation treatments, the present invention allows the subject to walk about conveniently, or otherwise exercise as appropriate, to establish good blood circulation during treatment. Subjects characterized by poor or impaired blood circulation are often candidates for chelation treatment. The chelation agent is excreted through the kidneys rather quickly and improved blood circulation tends to better distribute the chelation agent while it remains available in the system. The better distribution of course better utilizes such dosage of the chelation agent.
The EDTA series of polyaminocarboxylic acids has proven to be the most effective therapeutic chelating agents. Of these, the preferred agents are ethylene diamine tetra acetic acid (EDTA), and trans 1,2-cyclohexane diamine tetra acetic acid (CDTA), which are considered the best. EDTA is the agent most commonly used in medicine although CDTA has physical characteristics which makes it the superior to EDTA under certain circumstances and is the only compound found to be superior to EDTA as an overall complexing agent. EDTA is usually compounded as the disodium or tetrasodium salt and sometimes the calcium salt. Some of the commercial EDTA products are Cheladrate (Farmex), Disotate (Fellows), and Edetate (Abbott) and are those commonly used in chelation therapy. The sodium salt of EDTA is generally used in medicine because it increases the solubility of the chelating agents.
Informative sources concerning EDTA, as found in the development of the present invention, are U.S. Pat. Nos. 2,387,735; 2,407,645; 2,698,823; 2,781,291; 2,785,174; 3,308,065; 3,367,834; and 3,438,811. An informative publication is B. W. Halstead, The Scientific Basis of EDTA Chelation Therapy, Golden Quill Publishers, Inc., Colton, Calif., Copyright 1979. U.S. Pat. No. 2,698,823 discloses the uses of an ointment containing EDTA to give a creamy emulsion for daily skin application.
Dimethylsulfoxide (DMSO) is another significant component of the present invention. See U.S. Pat. Nos. 2,581,050 and 3,045,051. DMSO has been found to be an excellent solvent and penetrant through organic material with interactions between DMSO and other substances increasing in proportion to the polarizibility of the substance. DMSO is reported to be an unexcelled internal penetrating carrier of pharmaceuticals to any part of the body for a therapeutic effect. DMSO passes through cellular membranes and tissues. DMSO is able to penetrate endothelial coatings of the arterial walls, meninges of the brain, healthy skin, mucus membranes, and the various other tissues constituting a living body.
In the United States DMSO is currently regarded as an experimental drug for human use and has been released as a veterinary prescription drug. Currently, DMSO has been approved by the United States Food and Drug Administration (FDA), for use in treatment of interstitial cystitis. Other countries have used the drug therapeutically for more than two decades. The only mention of DMSO found in the therapeutic patent literature is in U.S. Pat. No. 4,201,211 where clonidine is administered transdermally by a skin patch product. There, the inventor recommends that the skin be prepared prior to the application of the skin patch by a skin permeation enhancing agent such as dodecylpyrrolidone, dimethyl lauramide or dimethylsulfoxide which is removed before application of the patch.
An informative publication is Morton Walker, DMSO, The New Healing Power, Devin-Adair Publishers, Old Greenwich, Conn., Copyright 1983. While this publication outlines many therapeutic qualities and characteristics of DMSO, it is to be noted that its primary function in the present invention is its excellent drug transporting characteristics.
Skin patch products, as used in the present invention, are generally available commercially for the transdermal administration of drugs such as nitroglycerin and the antihypertension drugs, clonidine, and captopril, for example. Such products are disclosed in more detail in U.S. Pat. Nos. 3,454,701; 4,201,211; 4,486,193; and 4,592,753.
An exemplary example of EDTA suitable for use in the present invention is Edetate Disodium U.S.P. Product No. 0277-20 as manufactured by Carter-Global Laboratories, Inc., Glendale, Ariz., 85301. The DMSO, used in the present invention, must be of pharmaceutical grade. The other compositions as may be used must also be of pharmaceutical grade.
It is to be noted that U.S. Pat. Nos. 2,698,823; 4,486,193; and 4,201,211 are hereby specifically incorporated into this specification by reference.